Effects of sevoflurane versus other general anaesthesia on emergence agitation in children

David Costi; Allan M Cyna; Samira Ahmed; Kate Stephens; Penny Strickland; James Ellwood; Jessica N Larsson; Cheryl Chooi; Laura L Burgoyne; Philippa Middleton

doi:10.1002/14651858.CD007084.pub2

Binstock 2004

Methods	Randomized controlled trial
Participants	2‐10 years, ASA I‐II, day case surgery Exclusion criteria: none stated Recruitment: 129 children randomly assigned, 125 analysed (23 group 1, 27 group 2, 25 group 3, 26 group 4, 24 group 5) Location: USA
Interventions	5 groups to study the effects of 2 different doses of oral transmucosal fentanyl (OTFC) premedication with or without ondansetron: Group 1: OTFC normal dose (10‐15 mcg/kg) premedication + ondansetron 0.1 mg/kg IV Group 2: OTFC normal dose (10‐15 mcg/kg) premedication + placebo Group 3: placebo + ondansetron 0.1 mg/kg IV Group 4: placebo + placebo Group 5: OTFC low dose (100 mcg fixed dose) premedication + placebo All participants: sevoflurane with nitrous oxide for induction and maintenance, caudal blocks with 0.125% bupivacaine for surgery below umbilicus
Outcomes	Postoperative "anxiety/agitation" defined as not "calm" but "clinging or apprehensive" or "crying" in PACU. Time point used in forest plot is upon arrival in PACU Other outcomes: number of participants requiring analgesia in PACU, caregiver and parental satisfaction, PONV, respiratory events, time to emergence, time in PACU
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"randomly assigned," method of random sequence generation not stated
Allocation concealment (selection bias)	Unclear risk	method of allocation concealment not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"all study drugs and placebos were prepared by the OR pharmacy and labelled with only the patients' name and hospital numbers"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"patients were monitored after anesthesia by an independent blinded observer"
Incomplete outcome data (attrition bias) All outcomes	Low risk	4 withdrawals reported for the following reasons: attending anaesthetists did not approve of the child's enrolment after study of drug administration anaesthetic gas was changed intraoperatively surgery was cancelled after study drug was opened discretion of anaesthetist was applied in the interest of participant's health
Selective reporting (reporting bias)	Low risk	reported incidence of "anxiety/agitation"